Point-of-care Management of Coagulopathy in Lung Transplantation

NCT03598907 | Terminated Results

• 1 other identifier: NV19-06-00471
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary transplantation is a very demanding surgical procedure, often accompanied by coagulopathy and severe perioperative bleeding. The most common complication that develops within the first 72 hours after surgery is primary graft dysfunction (PGD), up to 30% in the most severe form. The etiology of PGD is multifactorial. One of the causes may be the amount of perioperative blood loss. Intravascular volume is normally maintained by the administration of crystalloid and colloid solutions and fresh frozen plasma, which is also used to treat coagulopathy, however it is administered at the discretion of the anaesthetist and his experience, practically meaning ,,blindly". In the field of the allogeneous ischemic organ, these substitution solutions essentially become another allogeneous material and can cause undesired immunomodulation and contribute to the development of PGD. In our prospective randomized trial (120 patients), two patient groups will be investigated. In the first group, the coagulopathy and perioperative blood loss will be treated by the current standard approach, by ,,blind" administration of fresh frozen plasma, crystalloids and colloids. In the second group, the cause of coagulopathy will be diagnosed and treated according to the point-of-care (POC) results of ROTEM, PFA 200 and Multiplate. A colloidal solution of 5% albumin will be used to replace the circulating volume and maintain the oncotic pressure. Investigators assume that the POC management of coagulopathy and bleeding in the second group will lead to a reduction in perioperative bleeding, to reduced administration of infusion solutions, and thus to a reduction of the incidence of PGD.

Conditions

Lung Transplantation

Keywords

point of care; coagulopathy; lung transplantation; primary graft dysfunction

Outcome Measures

Primary Outcomes (1)

• Perioperative Blood Loss

  Total estimated blood loss measured during the perioperative period of lung transplantation (including intraoperative and immediate postoperative period).

  From the beginning of surgery to 24 hours postoperatively

Other Outcomes (4)

• Primary Graft Dysfunction (PGD)

  After surgery at 0 hours

• Primary Graft Dysfunction (PGD)

  After surgry at 24 hours

• Primary Graft Dysfunction (PGD)

  After surgry at 48 hours

Study Arms (2)

Standard management of coagulopathy

The first group of existing ,,standard care" - the approach to bleeding patient will be based on clinical experience of the anaesthetist, practically meaning administering crystalloids, colloids (hydroxyethyl starch or gelatin), fresh frozen plasma and erythrocytes to restore normovolemia and platelets, fibrinogen, prothrombin complex concentrate, von Willebrand factor, tranexamic acid, all products giving ,,blindly" when it comes to diagnosis and treatment of coagulopathy.

Other: Fresh frozen plasma

POC management of coagulopathy

group of ,,point-of-care" approach to the diagnosis and treatment of perioperative bleeding and coagulopathy will be conducted on the basis of the results of the POC methods ROTEM, PFA 200 and Multiplate (prothrombin complex concentrate, fibrinogen, platelets, von Willebrand factor, tranexamic acid). A solution of 5% albumin and erythrocytes (to keep haemoglobin level over 100 g/l as it is critical for normal primary haemostasis) will be used to keep normal circulating volume and to compensate for perioperative blood loss.

Interventions

Fresh frozen plasma OTHER

Fresh frozen plasma will be used according to anaesthetist ,,blind,, decision

Standard management of coagulopathy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over 18 years old who are indicated for bilateral lung transplantation with diagnosis of interstitial pulmonary fibrosis, cystic fibrosis, chronic obstructive pulmonary disease, exogenous allergic alveolitis.

You may qualify if:

• Patients over 18 years
• Indicated for bilateral lung transplantation with diagnosis of interstitial pulmonary fibrosis, cystic fibrosis, chronic obstructive pulmonary disease, exogenous allergic alveolitis

You may not qualify if:

• Patients requiring plasmapheresis before lung transplantation
• Patients waiting for lung transplantation on ECMO (ECMO used as bridging to surgery)
• Patients undergoing simultaneous lung and heart transplantation

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

University Hospital Motol, Department of Anaesthesiology and Intensive Care

Prague, 150 06, Czechia

Location

Related Publications (16)

• Snell GI, Yusen RD, Weill D, Strueber M, Garrity E, Reed A, Pelaez A, Whelan TP, Perch M, Bag R, Budev M, Corris PA, Crespo MM, Witt C, Cantu E, Christie JD. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction, part I: Definition and grading-A 2016 Consensus Group statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2017 Oct;36(10):1097-1103. doi: 10.1016/j.healun.2017.07.021. Epub 2017 Jul 26. No abstract available.

  PMID: 28942784 BACKGROUND

• Diamond JM, Arcasoy S, Kennedy CC, Eberlein M, Singer JP, Patterson GM, Edelman JD, Dhillon G, Pena T, Kawut SM, Lee JC, Girgis R, Dark J, Thabut G. Report of the International Society for Heart and Lung Transplantation Working Group on Primary Lung Graft Dysfunction, part II: Epidemiology, risk factors, and outcomes-A 2016 Consensus Group statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2017 Oct;36(10):1104-1113. doi: 10.1016/j.healun.2017.07.020. Epub 2017 Jul 26. No abstract available.

  PMID: 28802530 BACKGROUND

• Gelman AE, Fisher AJ, Huang HJ, Baz MA, Shaver CM, Egan TM, Mulligan MS. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction Part III: Mechanisms: A 2016 Consensus Group Statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2017 Oct;36(10):1114-1120. doi: 10.1016/j.healun.2017.07.014. Epub 2017 Jul 24. No abstract available.

  PMID: 28818404 BACKGROUND

• Gorlinger K, Saner FH. Prophylactic plasma and platelet transfusion in the critically Ill patient: just useless and expensive or even harmful? BMC Anesthesiol. 2015 Jun 9;15:86. doi: 10.1186/s12871-015-0074-0.

  PMID: 26054337 BACKGROUND

• Keene DD, Nordmann GR, Woolley T. Rotational thromboelastometry-guided trauma resuscitation. Curr Opin Crit Care. 2013 Dec;19(6):605-12. doi: 10.1097/MCC.0000000000000021.

  PMID: 24240827 BACKGROUND

• Hagemo JS, Christiaans SC, Stanworth SJ, Brohi K, Johansson PI, Goslings JC, Naess PA, Gaarder C. Detection of acute traumatic coagulopathy and massive transfusion requirements by means of rotational thromboelastometry: an international prospective validation study. Crit Care. 2015 Mar 23;19(1):97. doi: 10.1186/s13054-015-0823-y.

  PMID: 25888032 BACKGROUND

• Mutlak H, Reyher C, Meybohm P, Papadopoulos N, Hanke AA, Zacharowski K, Weber CF. Multiple electrode aggregometry for the assessment of acquired platelet dysfunctions during extracorporeal circulation. Thorac Cardiovasc Surg. 2015 Feb;63(1):21-7. doi: 10.1055/s-0034-1383817. Epub 2014 Aug 1.

  PMID: 25083831 BACKGROUND

• Kalbhenn J, Schlagenhauf A, Rosenfelder S, Schmutz A, Zieger B. Acquired von Willebrand syndrome and impaired platelet function during venovenous extracorporeal membrane oxygenation: Rapid onset and fast recovery. J Heart Lung Transplant. 2018 Aug;37(8):985-991. doi: 10.1016/j.healun.2018.03.013. Epub 2018 Mar 17.

  PMID: 29650295 BACKGROUND

• Bogdanic D, Karanovic N, Mratinovic-Mikulandra J, Paukovic-Sekulic B, Brnic D, Marinovic I, Nonkovic D, Bogdanic N. The Role of Platelet Function Analyzer Testing in Cardiac Surgery Transfusion Management. Transfus Med Hemother. 2017 Apr;44(2):106-113. doi: 10.1159/000452863. Epub 2017 Feb 1.

  PMID: 28503127 BACKGROUND

• Ellis J, Valencia O, Crerar-Gilbert A, Phillips S, Meeran H, Sharma V. Point-of-care platelet function testing to predict blood loss after coronary artery bypass grafting surgery: a prospective observational pilot study. Perfusion. 2016 Nov;31(8):676-682. doi: 10.1177/0267659116656774. Epub 2016 Jul 10.

  PMID: 27388540 BACKGROUND

• Deppe AC, Weber C, Zimmermann J, Kuhn EW, Slottosch I, Liakopoulos OJ, Choi YH, Wahlers T. Point-of-care thromboelastography/thromboelastometry-based coagulation management in cardiac surgery: a meta-analysis of 8332 patients. J Surg Res. 2016 Jun 15;203(2):424-33. doi: 10.1016/j.jss.2016.03.008. Epub 2016 Mar 26.

  PMID: 27363652 BACKGROUND

• Pearse BL, Smith I, Faulke D, Wall D, Fraser JF, Ryan EG, Drake L, Rapchuk IL, Tesar P, Ziegenfuss M, Fung YL. Protocol guided bleeding management improves cardiac surgery patient outcomes. Vox Sang. 2015 Oct;109(3):267-79. doi: 10.1111/vox.12279. Epub 2015 Apr 30.

  PMID: 25930098 BACKGROUND

• Leon-Justel A, Noval-Padillo JA, Alvarez-Rios AI, Mellado P, Gomez-Bravo MA, Alamo JM, Porras M, Barrero L, Hinojosa R, Carmona M, Vilches-Arenas A, Guerrero JM. Point-of-care haemostasis monitoring during liver transplantation reduces transfusion requirements and improves patient outcome. Clin Chim Acta. 2015 Jun 15;446:277-83. doi: 10.1016/j.cca.2015.04.022. Epub 2015 Apr 25.

  PMID: 25916692 BACKGROUND

• Durila M, Vajter J, Garaj M, Pollert L, Berousek J, Vachtenheim J Jr, Vymazal T, Lischke R. Rotational thromboelastometry reduces blood loss and blood product usage after lung transplantation. J Heart Lung Transplant. 2021 Jul;40(7):631-641. doi: 10.1016/j.healun.2021.03.020. Epub 2021 Mar 29.

  PMID: 33934981 RESULT

• Vajter J, Vachtenheim J Jr, Prikrylova Z, Berousek J, Vymazal T, Lischke R, Martin AK, Durila M. Effect of targeted coagulopathy management and 5% albumin as volume replacement therapy during lung transplantation on allograft function: a secondary analysis of a randomized clinical trial. BMC Pulm Med. 2023 Mar 9;23(1):80. doi: 10.1186/s12890-023-02372-0.

  PMID: 36894877 RESULT

• Durila M, Vajter J, Garaj M, Smetak T, Hedvicak P, Berousek J, Vymazal T. Acquired primary hemostasis pathology detected by platelet function analyzer 200 seen during extracorporeal membrane oxygenation is sufficient to prevent circuit thrombosis: A pilot study. J Heart Lung Transplant. 2020 Sep;39(9):980-982. doi: 10.1016/j.healun.2020.05.015. Epub 2020 Jun 11. No abstract available.

  PMID: 32591313 DERIVED

MeSH Terms

Conditions

Hemostatic Disorders; Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: prof. Miroslav Durila
• Organization: Department of anesthesiology and intensive care medicine, Charles University and Motol Hospital

miroslav.durila@fnmotol.cz

+420224435440

Study Officials

• Miroslav Durila, assoc.prof.

  University Hospital, Motol

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: July 26, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 10, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)